Efficacy of a Self-advocacy Serious Game Intervention
Individuals with cancer must overcome multiple, ongoing challenges ("self-advocate") related to their cancer experience to receive patient-centered care. Women with metastatic cancer often face significant challenges managing their quality of life concerns and cancer- and treatment-related symptoms. If they do not self-advocate to manage these concerns, they risk having poor quality of life, high symptom burden, and care that is not patient-centered. Serious games (video games that teach) are effective health interventions that allow users to vicariously engage in situations reflecting their personal experiences, receive meaningful information, and learn personally relevant skills that they can apply in real life. The goal of the current study is to test the efficacy of a novel intervention using a serious game platform to teach self-advocacy skills to women with advanced cancer. The Strong Together intervention consists of a multi-session, interactive serious game application with tailored self-advocacy goal-setting and training. The serious game is based on a self-advocacy conceptual framework and applies behavior change theories and serious game mechanisms to promote skill development and implementation. The game works by immersing users in the experiences of characters who are women with advanced cancer; requiring users to make decisions about how the characters self-advocate; demonstrating the positive and negative consequences of self-advocating or not, respectively; and providing multiple, individualized feedback mechanisms and game features to enforce self-advocacy skill acquisition and transference to real life.
Conditions:
🦠 Self-Management 🦠 Quality of Life
🗓️ Study Start (Actual) 22 August 2022
🗓️ Primary Completion (Estimated) 15 January 2026
✅ Study Completion (Estimated) 31 August 2026
👥 Enrollment (Estimated) 336
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Female
    • * ≥18 years
    • * Diagnosed with advanced solid organ cancer within the past 6 months being treated with non-curative intent
    • * Have at least a 6-month life expectancy (as determined by their oncologist)
    • * Eastern Cooperative Oncology Group performance score of 0 to 2 (per health record or oncologist)
    • * Able to read and write in English

    Exclusion Criteria:

    • * On hospice at the time of recruitment
    • * Impaired cognition (per health record)
    • * Other active, unstable mental health disorder
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 March 2021
  • First Submitted that Met QC Criteria 20 March 2021
  • First Posted 24 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 July 2024
  • Last Update Posted 15 July 2024
  • Last Verified July 2024